With all of Nucleus Radiopharma’s manufacturing facilities built to exceed compliance with 21 CRF 211, our proactive design will help you meet radiopharmaceutical regulatory, safety, and operational requirements today and into the future.
Quality & Regulatory
Lead with radiopharmaceutical quality assurance excellence to avoid future disruptions
- 21 CFR Part 210/211
- ISO 13408-6
- cGMP expected in 2025
Leverage first-hand expertise in quality control of radiopharmaceuticals
Radiopharmaceutical quality control requires specialized expertise, as diagnostics and radiotherapies have distinct regulatory and safety challenges.
Our team ensures rigorous quality oversight to prevent disruptions, protect patient safety, and maintain compliance at every stage.
Quality assurance and regulatory compliance overview:
- cGMP-compliant facilities designed to meet evolving FDA, NRC, and USDOT standards
- Comprehensive quality control oversight from R&D through commercial production to ensure consistency and safety
Radiopharmaceutical regulatory services:
- QMS real-time monitoring for proactive compliance management
- Audit-ready documentation with detailed reporting and tracking
Why Nucleus RadioPharma for your radiopharmaceutical quality and regulatory needs?
- Dedicated R&D space, separate from manufacturing, to optimize quality before full-scale production
- Compliance that goes beyond industry standards for seamless regulatory approvals, audit readiness, and risk mitigation
